Antihistamine to prevent hypotensive transfusion reactions after blood-primed cardiopulmonary bypass in children
Official title: Prophylactic Antihistamine for Prevention of Hypotensive Transfusion Reaction After Blood Primed Cardiopulmonary Bypass in Pediatric Cardiac Surgery: a Randomized-controlled Study
Run by Kasr El Aini Hospital · NCT07536152 · Data updated 2026-11-12
This randomized, double-blind trial will test whether a single IV dose of chlorpheniramine given after separation from cardiopulmonary bypass can prevent hypotensive transfusion reactions in children aged 1–7 undergoing elective repair of acyanotic congenital heart defects.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 1 Year to 7 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Kasr El Aini Hospital Academic / other |
| Locations | 1 site (Giza, October) |
| Status | Recruiting |
| Started | March 1, 2026 |
| Main results expected | November 2026 |
| Study ends | December 2026 |
| Registry record updated | April 21, 2026 |
| Trial ID | NCT07536152 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 1–7 with acyanotic congenital heart defects scheduled for elective repair using blood-primed cardiopulmonary bypass who have no antihistamine allergy, significant bleeding disorder, or planned redo/emergency procedure.
✕Probably not a fit
Children outside the 1–7 age range, those with cyanotic defects, redo or emergency cases, active bleeding disorders (INR > 1.5 or platelets < 50,000), or known antihistamine allergy are unlikely to be eligible or to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, double-blind, placebo-controlled trial at a university hospital enrolling 40 children undergoing elective repair of acyanotic congenital heart defects with blood-primed cardiopulmonary bypass. Patients are randomized 1:1 (20 per group) to receive a single intravenous dose of combined chlorpheniramine or normal saline immediately after separation from bypass and before protamine administration. Key inclusion criteria are age 1–7 years and acyanotic congenital heart disease, while exclusions include redo surgery, antihistamine allergy, significant bleeding disorders, and emergency procedures. The study will monitor hemodynamic responses and transfusion-related adverse reactions to see if prophylactic antihistamine reduces hypotensive transfusion reactions and is safe in this setting.
Why it matters
Potential benefit: If successful, a single dose of chlorpheniramine could lower the risk of hypotensive transfusion reactions and improve blood pressure stability during recovery after bypass in young children.
How similar studies have gone: Antihistamines are widely used to treat allergic transfusion reactions, but randomized data specifically showing prevention of hypotensive transfusion reactions after blood-primed pediatric CPB are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Acyanotic congenital heart disease. * Age :1 -7 years. * Genre: both. Exclusion Criteria: * Redo patient. * History of allergy to antihistamines. * Bleeding disorders with INR \> 1.5 and/or platelets \< 50,000. * Emergency procedure.
Where it's running
-
Misr Universty for Scince and Technology
Giza, October, Egypt Recruiting
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.